Large cell neuroendocrine carcinoma
Conditions
Interventions
cisplatin 6mg/m2, day1 irinotecan 6mg/m2, day1, day8, day15 every 4 weeks
Sponsors
National Cancer Research Center Hospital East
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) recurrent disease after surgery or unresectable large cell neuroendocrine carcinoma which is histologically confirmed 2) age:20-75 years old 3) performance status (ECOG performance status score)0-1 4) measurable lesion 5) no prior chemotherapy with platinum-based or irinotecan regimen 6) adequate organ function: .WBC>=4000/mm3 .Hemoglobin>=9.5g/dL .Platelet count >=100000/mm3 .Total serum bilirubin<=1.5mg/dL .GOT, GPT<100IU/L .Serum creatinine<=1.5mg/dL .PaO2>=65mmHg 7) written informed consent 8) survival period is expected to be more than 3 months
Exclusion criteria
Exclusion criteria: 1) unresectable disease with indication for chest radiotherapy 2) uncontrolled pleural/pericardial effusion 3) active concomitant malignancy 4) interstitial pneumonia or pulmonary fibrosis as determined by chest x-ray 5) watery diarrhea 6) intestinal obstruction or paralysis 7) symptomatic brain metastasis 8) severe complications: .uncontrolled angina, myocardial infarction within the previous 3 months, severe cardiac failure 9) pregnant or lactating women 10) psychological disease deemed unacceptable for inclusion to the study 11) severe drug allergy 12) doctor's decision not to be registered to this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival, progression free survival, adverse event | — |
Countries
Japan
Contacts
Public ContactSeiji Niho
National Cancer Research Center Hospital East Thoracic Oncology Division
Outcome results
None listed